Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1060934

FEI Number

3000209706

Entity Name

COLDSTAR INTERNATIONAL INC

City/State/Country

Bristol, TN, US

Establishment Address

302 ROSEDALE LN, Bristol, TN 37620, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

COLDSTAR INTERNATIONAL, INC. (Owner Number: 9027493)

Owner / Operator Contact Address

302 Rosedale Lane, --, Bristol, TN 37620, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hot Pack Cold Pack HOT COLD GEL PACKS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2009-05-11
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	1996-08-16

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

COLDSTAR INTERNATIONAL, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

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3003255790	WITKO INCORPORATED	Wolcott, IN, US
3008742818	PT. Hisamitsu Pharma Indonesia	Sidoarjo Jawa Timur, ID

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1060934. Last updated year: 2026. Please use registration number 1060934 when referencing this establishment in official correspondence.